HivNCT03454373
Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
A study testing Incentive for linkage to care in people with Hiv, run by University of California, Berkeley at 3 sites in Tanzania.
Trial summary
This protocol is for the long term follow-up study of "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy (ART) in Tanzania", a 3-arm randomized controlled trial led by Professor Sandra McCoy at the University of California Berkeley and Dr. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv
- What is being tested?
- Incentive for linkage to care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 3 sitesTanzania
- Study dates
- 1 Mar 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study participant in the prior study "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania" (NCT01957917)
- Alive and willing to provide written informed consent
- Not currently enrolled in HIV care services
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
Tanzania3 sites
Kambarage Health Center
Shinyanga, Shinyanga
Shinyanga Regional Hospital
Shinyanga, Shinyanga
Kahama District Hospital
Shinyanga
About this study
This protocol is for the long term follow-up study of "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy (ART) in Tanzania", a 3-arm randomized controlled trial led by Professor Sandra McCoy at the University of California Berkeley and Dr. Prosper Njau at the Tanzanian Ministry of Health and Social Welfare. The investigators will determine the long-term effectiveness of short-term incentives for ART adherence and retention in care. The study will also determine whether incentives can also be used to re-engage PLHIV with HIV care after they have fallen out of care.
Read the detailed description
This study will build on preliminary data from a randomized study conducted in Shinyanga, Tanzania which found that short-term cash and food assistance improved ART adherence and retention in care among food insecure people living with HIV infection (PLHIV) after 6 and 12 months of follow-up. The investigators will now determine the long-term effectiveness of these incentive strategies. In this 2-year study, investigators will first determine 24-month adherence and retention outcomes using medical and pharmacy records for the 781 PLHIV who were alive at the end of the previous study, which concluded after 12 months of follow-up (Aim 1). Then, leveraging an existing program of home based care, investigators will determine the prevalence of undocumented transfers and deaths among the subset of patients found to be lost to follow-up or transferred in clinic records. Investigators will use these data from home visits to adjust estimates of the interventions' effectiveness on retention in HIV care and mortality (Aim 2). Among the PLHIV found to be disengaged from care, investigators will conduct a pilot study of a one-time cash incentive to encourage PLHIV to re-engage with care, with the goal of mitigating the barriers posed by transportation and opportunity costs (Aim 3). At the conclusion of the project, investigators will understand the long-term effectiveness of cash and food incentives for adherence and retention, and whether they can also be used for re-linking PLHIV to care, data highly relevant to 'Treat All' programs in Fast Track countries.
- Conditions
- Hiv
- Being tested
- Incentive for linkage to care
- Keywords
- HIV, Food Insecurities, Antiretroviral Therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive for linkage to careBehavioural
Participants who were found to have been lost to care will receive standard of care plus a one-time "re-start" incentive of 22,500 TZS to return to care
| Study group | Role | What they receive |
|---|---|---|
| Incentive for return to care | Experimental | Standard of care HIV primary care services, including counseling to return to care, plus a one-time "re-start" incentive of 22,500 TZS to return to care. Receives: Behavioral: Incentive for linkage to care |
| Comparator | No intervention | Standard of care HIV primary care services, including counseling to return to care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of PLHIV linked to HIV care at 3 months
Initial re-engagement in care, defined as as the proportion of PLHIV who have completed (attended) a HIV primary care visit at the clinic of the PLHIV's choosing within 3 months of the incentive offer to return to care.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Mar 2018
- Primary completion12 Sep 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Ministry of Health and Social Welfare, Tanzania
- Responsible party
- Principal investigator, Sandra McCoy, University of California, Berkeley
- Investigators
- Sandra I McCoy, MPH, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454373
- Sponsor's protocol ID
- 2017-11-10508
- Status last verified
- Nov 2020
- First submitted
- 15 Feb 2018
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
- ClinicalTrials.gov ID
- NCT03454373
- Acronym / sponsor ID
- 2017-11-10508
- Conditions
- Hiv
- Keywords
- HIV, Food Insecurities, Antiretroviral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Ministry of Health and Social Welfare, Tanzania
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is for the long term follow-up study of "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy (ART) in Tanzania", a 3-arm randomized controlled trial led by Professor Sandra McCoy at the University of California Berkeley and Dr. Prosper Njau at the Tanzanian Ministry of Health and Social Welfare. The investigators will determine the long-term effectiveness of short-term incentives for ART adherence and retention in care. The study will also determine whether incentives can also be used to re-engage PLHIV with HIV care after they have fallen out of care.
Detailed description
This study will build on preliminary data from a randomized study conducted in Shinyanga, Tanzania which found that short-term cash and food assistance improved ART adherence and retention in care among food insecure people living with HIV infection (PLHIV) after 6 and 12 months of follow-up. The investigators will now determine the long-term effectiveness of these incentive strategies. In this 2-year study, investigators will first determine 24-month adherence and retention outcomes using medical and pharmacy records for the 781 PLHIV who were alive at the end of the previous study, which concluded after 12 months of follow-up (Aim 1). Then, leveraging an existing program of home based care, investigators will determine the prevalence of undocumented transfers and deaths among the subset of patients found to be lost to follow-up or transferred in clinic records. Investigators will use these data from home visits to adjust estimates of the interventions' effectiveness on retention in HIV care and mortality (Aim 2). Among the PLHIV found to be disengaged from care, investigators will conduct a pilot study of a one-time cash incentive to encourage PLHIV to re-engage with care, with the goal of mitigating the barriers posed by transportation and opportunity costs (Aim 3). At the conclusion of the project, investigators will understand the long-term effectiveness of cash and food incentives for adherence and retention, and whether they can also be used for re-linking PLHIV to care, data highly relevant to 'Treat All' programs in Fast Track countries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive for return to care | Experimental | Behavioral: Incentive for linkage to careStandard of care HIV primary care services, including counseling to return to care, plus a one-time "re-start" incentive of 22,500 TZS to return to care. |
| Comparator | No intervention | –Standard of care HIV primary care services, including counseling to return to care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Study participant in the prior study "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania" (NCT01957917)
- Alive and willing to provide written informed consent
- Not currently enrolled in HIV care services
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentive for linkage to careParticipants who were found to have been lost to care will receive standard of care plus a one-time "re-start" incentive of 22,500 TZS to return to care | Behavioural | Incentive for return to care |
Primary outcome
The proportion of PLHIV linked to HIV care at 3 months
Time frame: 3 months
Initial re-engagement in care, defined as as the proportion of PLHIV who have completed (attended) a HIV primary care visit at the clinic of the PLHIV's choosing within 3 months of the incentive offer to return to care.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra I McCoy, MPH, PhD principal investigator
University of California, Berkeley
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive for linkage to care in people with Hiv, run by University of California, Berkeley at 3 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of PLHIV linked to HIV care at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.